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Confidently detect and quantify trace nitrosamine and other mutagenic impurities

N-nitroso impurities have been a continued focus for regulatory agencies such as the FDA and EMA with the FDA announcing recalls of several medicines. Even in trace amounts, these impurities can be genotoxic and potentially carcinogenic. To ensure accuracy, sensitive analytical strategies are required allowing very low limits of detection. Agilent can help you address regulatory requirements with expertise and proven workflows, including GC/MS, LC/MS, and high-throughput LC/MS, to help you accurately and confidently identify and quantify these mutagenic impurities in APIs and drug products.

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Proven methods to simplify your analysis

Complete workflows, proven methods and tips for nitrosamine detection and quantification in several drug compounds

Addressing the Growing Demand for Nitrosamines Testing

Learn a proven solution for the quantification of the 16 EMA-regulated nitrosamines by LC-MS/MS.

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Nitrosamines in Sartan, Ranitidine, and Metformin

Learn current regulatory guidelines and GC/MS- and LC/MS-based analytical strategies to detect and quantify nitrosamines in APIs and drug products.

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Quantitation of Nitrosamine Impurities and NDSRI

Discover Multi Residue Methods for comprehensive analysis of 8 nitrosamines in losartan drug product, and quantification of NDSRIs in various drugs 

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LC/MS-based strategies for the confident analysis of nitrosamines

The identification and quantification of trace azido, NDSRI, and nitrosamine impurities in drug substances and products are under increased regulatory scrutiny. LC/MS-based analytical strategies can be easily adopted.

"Agilent has developed quantitative workflows that enable highly sensitive quantification of N-nitrosamine in various challenging APIs and formulation products using their LC/TQ, which can deliver detection limits even lower than those specified by the regulatory requirements.”
Dr. A. Siva Lakshmi Devi 


GC/MS-based strategies for the confident analysis of nitrosamines

The U.S. Food and Drug Administration published GC/MS-based analytical testing methods to provide options to detect nitrosamine impurities in drugs. Find proven GC/MS-based analytical strategies for the accurate identification and quantification of a range of nitrosamines in APIs and drug products.

 


Make LC and GC column and consumables selection easy

Pharmaceutical impurities analysis can be a difficult and time-consuming process. Agilent provides ordering guides and selection tools to help you quickly choose the right columns, standards, reagents, and supplies for your analysis. Agilent can help you obtain the resolution and performance you need.



Featured application notes

A comprehensive analysis of eight nitrosamine compounds was carried oon the Agilent 6495D triple quadrupole LC/MS system coupled with the Agilent 1290 Infinity II LC system and Agilent APCI source.  The study demonstrated that the Agilent 6495D LC/MS system can quantify nitrosamine impurities at levels as low as 0.01 ng/mL or 10 ppt, below the concentration level required by regulatory requirements, with high confidence. This method can be used to quantify these impurities in different ARB drug products with some alterations in chromatographic conditions, based on the elution pattern of the intended drug substance or drug product of interest

  

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Nitrosamine impurities are byproducts that are produced in trace amounts during the manufacturing process of pharmaceutical drugs. These impurities are classified as potentially genotoxic impurities and probable carcinogens with long-term intake. Therefore, it is important to determine their levels in final drug products with a high level of sensitivity and confidence. We evaluated the quantification performance of eight nitrosamine impurities using the Agilent 6475 triple quadrupole LC/MS (LC/TQ) system coupled with the Agilent 1290 Infinity II Bio LC system using an atmospheric pressure chemical ionization (APCI) source.

   

Confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements with the 6475 triple quadrupole LC/MS system.

  

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Explore a comprehensive solution for the screening and estimation of 13 nitrosamine impurities (NDMA, NDEA, NMOR, NMEA, NPYR, NPIP, NEIPA, NDIPA, NDPA, NDBA, NMPA, NMPEA, and NDPh) in drug products and drug substances in both organic or aqueous matrices at trace levels using an Agilent 8890 GC system coupled to an Agilent 7010 triple quadrupole GC/MS/MS system

   

The workflow was able to achieve good resolution between the 13 compounds, allowing for low detection limits and accurate, precise recovery

  

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